REDEFINE

Not yet recruitingPhase 3

A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

212

Recruiting sites

Estimated enrollment

1,408

Study population

Hypertension, Obesity / overweight

Eligibility highlights

•HbA1c 6.5-10%

Primary endpoint

•CagriSema

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07919405

Org study IDNN9838-8768

Secondary ID2026-526360-21European Medical Agency (EMA)

Secondary IDU1111-1338-1943World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-11-05actual

Last update posted2026-11-05actual

Study start2026-11-11estimated

Primary completion2028-06-01estimated

Study completion2028-07-13estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Who this study enrolls

HypertensionObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female (sex at birth).

•Age 18 years or above at the time of signing the informed consent.

•Resting in-office SBP of 140-160 mmHg (both inclusive) at screening (V1-Optional/V1) and the Run-in visit. Systolic blood pressure will be calculated as the mean of the second and third consecutive readings of triplicated blood pressure readings collected at 2-minute intervals with the blood pressure monitor provided by the Sponsor.

•Body mass index greater than or equal to (>=) 30.0 kilograms per metre square (kg/m^2) at screening.

•Not receiving Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) or antihypertensive medication or on stable (i.e., same drug(s), dose and dosing frequency) SGLT2i or antihypertensive treatment >= 30 days prior to screening.

For participants with Type 2 Diabetes (T2D)

The following inclusion criteria apply at screening in addition to the inclusion criteria listed above:

•Diagnosed with T2D >= 90 days before screening.

•Glycated Haemoglobin (HbA1c) 6.5-10.0% (48-86 millimoles per mole (mmol/mol)) (both inclusive) as measured by the central laboratory at screening.

•Treatment with either lifestyle intervention only, or treatment with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors, glinides, SGLT2i or thiazolidinediones, as a single agent or in combination) according to local label.

•Treatment with antidiabetic medication should be stable (i.e., same drug(s), dose and dosing frequency) for at least 90 days before screening.

Exclusion criteria

•Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1).

•Known secondary hypertension due to renovascular hypertension (renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, acromegaly, coarctation of the aorta, or any other identifiable cause of secondary hypertension.

•Currently under medical investigation for any cause of secondary hypertension.

•Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis.

•Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation.

•Moderate-to-severe anaemia with Hgb lesser than (<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening.

•A change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.

•Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

•Use of any Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin agonists, within 90 days before screening.

For participants without T2D

•HbA1c greater than or equal to >= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening.

•History of type 1 or type 2 diabetes mellitus.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight (%)

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (Kg)

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Primary/protocol endpoint

CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Secondary/protocol endpoint

Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg

Time frame:At Week 32

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve American College of Cardiology and the American Heart Association (ACC/AHA) guidelines based blood pressure targets lesser than (<) 130/80 mmHg

Time frame:At Week 32

threshold achievement, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: Total cholesterol

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: HDL cholesterol

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: Non-HDL cholesterol

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of lipids: Triglycerides

Time frame:From baseline (week 0) to week 32

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to week 32

ratio, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score

Time frame:From baseline (week 0) to week 32

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.